The primary purpose of this position is to coordinate and support our pediatric research initiatives according to regulatory requirements, institutional guidelines, and sponsor expectations. Duties include initiating new trials, coordinating the enrollment of eligible patients, tracking study activities and adverse events throughout trial participation, extracting and reporting quality patient data, and responding to data queries. This position reports to the Clinical Research Operations Manager/Lead CRA, but is accountable to the program leaders, the physician-investigators, and members of the research team. Persons in a CRC III position in this division are assigned higher acuity projects including complex research studies, Phase I studies, and other studies conducted under an IND.
Clinical Research Conduct & Facilitation (70%)
Independently manage a large and/or complex project, or portfolio of projects.
Act as information resource to University faculty and staff for protocol specific queries, including availability of trials, enrollment requirements, specimens needed, etc.
Engage with investigators in verifying subject eligibility, facilitating subject enrollments, ensuring the appropriate recording of adverse events, and acquisition of research samples.
Ensure timely and accurate data submission; engage with providers and investigators to ensure adequate source documentation is available; accurate interpretation and recording of data; maintenance of subject research charts.
Facilitate the timely review and reporting of adverse reactions and severe adverse events
Contribute to the production of research publications or presentations of research data
During a typical 8 hour shift, a person in this position may be required to stand up to 2.5 hours, walk up to 2.5 hours (including stairs), reach above shoulders, lift up to 10 pounds above the shoulder, and carry packages across campus at waist level.
Partner with Regulatory Specialist, the PI and the rest of the study team to ensure ethical conduct of clinical trials.
Provide documentation and reports related to subject experience on trials (adverse event reports, subject complaints, etc.) to the research team to ensure compliance with applicable policies, procedures and regulations.
Support the Investigators in ensuring the protection of all human research participants according to Federal regulations, University policies, and sponsor expectations.
Lead the preparation for and participate in site initiation visits, monitoring visits, program audits, etc. for assigned trials
Facilitate new project development and start-up activities.
Support quality improvement initiatives.
Attends national and study meetings as appropriate.
Support the training and mentoring of CRCs within the program and across Pediatrics.
Educate University faculty and staff of our regulatory and research obligations in relation to our clinical research activities.
Communicate with clinical teams to foster an environment of quality research participation within the context of exceptional clinical care.
BA/BS in a scientific or health related field and 4 years research experience, OR advanced degree plus 2 years research experience, OR a combination of education and experience in research to equal to 8 years
Relevant research certification, such as CCRP or CCRC, or will be qualified to obtain certification within six months of start date
At least 1-year experience conducting clinical research, preferably at the University of Minnesota
Demonstrated data management skills, preferably in a health-related setting, including data collection, generating reports, and ensuring data quality
Detail-oriented with exceptional organizational, planning and problem-solving skills
Ability to work independently, as a part of a team and with changing priorities
Demonstrated ability to maintain deadlines and prioritize assignments
Excellent written, verbal and interpersonal skills
Knowledge of federal regulations related to research with human subjects and protected health information
Ability to work flexible work hours, including occasional evenings and weekends.
Master’s Degree in related field
Experience with Epic electronic medical record system
Experience with pediatric populations
Experience with patient care / contact, and recruiting patients to clinical trials
Experience with specimen management skills, including processing human samples and shipping per regulations
Internal Number: 339378
About University of Minnesota, Twin Cities
The University of Minnesota, founded in the belief that all people are enriched by understanding, is dedicated to the advancement of learning and the search for truth; to the sharing of this knowledge through education for a diverse community; and to the application of this knowledge to benefit the people of the state, the nation, and the world.